On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
11/6/2023
/ Comment Period ,
Communication Restrictions ,
Evidentiary Standards ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Public Comment ,
Scientific Evidence
On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more
8/16/2023
/ Comment Period ,
Compliance ,
Cosmetics ,
Draft Guidance ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
Personal Care Products ,
Product Packaging ,
Registration Requirement ,
Safety Standards
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
6/29/2023
/ Comment Period ,
Draft Guidance ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Hospitals ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wholesale
Key Takeaways -
..On September 28, 2022, the FDA issued a proposed rule to update the criteria for which foods can be labeled as “healthy” to align the definition with current nutrition science.
..For the first time,...more